OPERATION & MAINTENANCE MANUAL Electronic Tabletop Autoclaves Models EZ9, EZ10, EZ10K Cat. No. MAN205-0263001EN Rev. E Tuttnauer USA Co., Ltd., 25 Power Drive Hauppauge, NY 11788 USA, : (800) 624 5836, (631) 737 4850, Fax: (631) 737 0720 e-mail: info@tuttnauerUSA.
TABLE OF CONTENTS PARAGRAPH 1. 2. 3. 4. 5. 6. 7. 8. PAGE NO. GENERAL.............................................................................................................4 1.1 Incoming Inspection..................................................................................4 1.2 Warranty ....................................................................................................4 1.3 Warranty Statement.................................................................................
TABLE OF CONTENTS (Cont.) PARAGRAPH PAGE NO. 9. MAINTENANCE INSTRUCTIONS..................................................................38 9.1 Preventive and Scheduled Maintenance.................................................38 9.2 Replacing the Air Filter...........................................................................39 9.3 Draining the Reservoir ............................................................................40 9.4 Cleaning the Air Jet........................................
TABLE OF CONTENTS (Cont.) DRAWINGS PAGE NO. Front View...................................................................................................................13 Rear View ....................................................................................................................14 Front Panel Keyboard.................................................................................................
1. GENERAL Read the Operating Instructions carefully, before beginning any operation on the autoclave! 1.1 Incoming Inspection Upon receiving your Tuttnauer Autoclave, carefully inspect the outside of the shipping carton for signs of damage. If any damage to the carton is found, note the location with respect to the autoclave and check that area of the autoclave carefully once it is fully unpacked. Observe packing method and retain packing materials until the unit has been inspected.
Note: If you have any questions or there are any difficulties with this instrument and the solution is not covered in this manual, please contact your dealer or Tuttnauer USA Co. Do not attempt to service this instrument yourself. Tuttnauer USA Co., Ltd., 25 Power Drive Hauppauge, NY 11788, USA : (800) 624 5836, (631) 737 4850, Fax: (631) 737 0720 e-mail:info@tuttnauerUSA.com.
2. TECHNICAL DATA 2.1 Introduction This tabletop autoclave is designed for the sterilization of wrapped and unwrapped instruments and related items found in dental, medical and veterinary clinics, first aid rooms, hospitals, laboratories, etc. This autoclave is an electrically heated sterilizer using steam as the sterilizing agent.
2.3 2.4 Environmental Emission Information 1. The peak sound level generated by the autoclave is less than 70 dBA with background noise of 60 dBA. 2. The total heat per hour transmitted by the autoclave is < 100 Wh for all models. Operating Conditions This device is to be used for indoor use. This autoclave is intended for NORMAL environment conditions as follows: ♦ Altitude up to 2000m. ♦ Room temperature range 5ºC to 40ºC. ♦ Installation Category II. ♦ Pollution Degree 2.
2.7 Symbol Description Caution! Consult accompanying documents. Caution! Hot surface. Caution! Hot steam. Protective earth (Ground).
2.8 Electrical Data EZ9 EZ10 EZ10K 6 6 9.6 Ampere (A) at 120V 11.7 11.7 Watts (W) 1400 1400 2200 Ampere (A) at 230/240V Frequency 50 / 60 Hz Degree of protection by enclosure IP31 AUTOCLAVE TYPE DESCRIPTION EZ9, EZ10 EZ10K 120V 230V 230V Circuit breaker (A) 15 10 15 Air pump fuse (A) 2.0 1.25 1.25 Water pump fuse (A) 1.25 1.25 1.
2.9 Specifications Overall Dimensions Model Dimensions Overall Dimensions Maximum Dimensions (door open) Distance Between Supporting Legs EZ9 EZ10, EZ10K A mm 510 in 20.0 mm 510 in 20.0 B 365 14.4 365 14.4 C 540 21.5 545 21.5 D 910 35.8 910 35.8 E 630 24.8 655 25.8 F 299 11.8 299 11.8 F1 422 16.6 422 16.6 G 50 2.0 50 2.0 H 400 15.8 400 15.8 3 lit. 0.8 gal. 3 lit. 0.8 gal. 0.8 lit. 0.21 gal. 0.8 lit. 0.21 gal.
2.10 Technical Specifications Models EZ9 EZ10, EZ10K 9.4 cu.ft. (0.27m3) 79 lbs. (36 kg) 9.4 cu. ft. (0.27m3) 106 lbs. (48 kg) Yes Yes Half 2 3 Full 2 3 3 4 6.7" x 16.3" x 0.8" (17 x 41.5 x 2cm) 0.66 US gal. (3.0 liters.) 5 US gal. (19 liters ) 9" x 18" (23 x 47 cm) 6.7" x 16.3" x 0.8" (17 x 41.5 x 2cm) 0.66 US gal. (3.0 liters.) 6 US gal. (23 liters) 10" x 19" (25.4 x 47.5cm) Shipping Volume Shipping Weight Printer No. of IMS Cassettes (Optional) No.
2.12 Water Quality The distilled or mineral free water supplied to the autoclave should have the physical characteristics and maximum acceptable level of contaminants indicated in the table below: Physical Characteristics and Maximum acceptable contaminants levels in steam for sterlizers Element Condensate – allowable content Silicium oxide. SiO2 ≤0.1 mg/kg Iron ≤0.1 mg/kg Cadmium ≤0.005 mg/kg Lead Rest of metals except iron, cadmium, lead Chloride (Cl) ≤ 0.05 mg/kg ≤0.1 mg/kg Phosphate (P2O5) ≤0.
FRONT VIEW No. Description No.
REAR VIEW 14
3. KEYBOARD (Keys and Display) FRONT PANEL KEYBOARD Note: See section 3.2 for a description of the Keyboard buttons Note: See section 3.
3.1 Indicator Light Description Programs Indicators Shows the selected program START Shows the system is running a program. HEAT The system is currently in the Heating stage. STE The system is currently in the Sterilization stage. EXH The system is in the Exhaust stage. DRY The system is in the Dry stage. FAIL Shows the system has failed as a result of either a malfunction, or the STOP key was pressed. A message is displayed on the screen; the reason for failure.
3.2 Description and Functions of the Control Panel Keyboard 3.2.1 Program keys (1) Unwrapped Instruments (2) Wrapped Instruments (3) Glassware (slow exhaust, no drying) Pressing one of the above program keys determines the chosen program. The program parameters are displayed and the program indicator lights. (4) Dry Only Pressing this key allows inclusion of the Additional Drying procedure for a period of time determined by the operator. Time range is 0-99 minutes. 3.2.2 Other keys (5) TEMP.
(9) DN Pressing these keys in combination with TEMP. (5), STE TIME (6), DRY Time (7) and CLOCK (9) lowers these values. (10) CLOCK Pressing the CLOCK programming key displays the date, with the cursor under the day. Pressing the UP or DN keys changes the date. Pressing the CLOCK key again moves the cursor to the month, then year and then time (hour, minute, second). At this point the display shows the currently set date and time.
(13) STOP This key issues the only command accepted by the system during the running of a program. Pressing this key for over 1 second causes the program to immediately cease running and enters the EXHAUST stage, at the end of which the “MAN. STOP” message will be displayed. This key has no function when the system is not in operation and its only use is to manually stop a cycle. In normal working conditions on completion, the system automatically terminates the cycle, without use of this key.
Message is displayed and sterilization does not start if the autoclave has not reached sterilization temperature after heating for 50 minutes while in the Wrapped or Unwrapped programs (80 minutes in the Glassware program). Possible causes: ♦ A clogged Air Jet (see cleaning the Air Jet sec 9.4). ♦ No power to the heating elements. ♦ Low line voltage delaying heat up. Low Pres Message is displayed, fail indicator lights, and the program is aborted if the pressure drops 4 psi (0.
Message is displayed, if during a normal heat up stage the system determines that there is insufficient water in the chamber to complete the cycle. This determination is made by the combined input of two sensors, the Water Electrode and the Safety Thermostat. Also, if a power failure occurs during the heat or sterilization stage after the power returns, the system will check the Water Electrode to see if there is sufficient water in the chamber in order to resume the cycle.
4. STERILIZATION PROGRAMS The autoclave offers 3 sterilization programs, at temperatures of up to 274°F (134°C), with or without a drying stage and 1 accessory (dry only) program. A. Three sterilization programs: 1. Unwrapped instruments. 2. Wrapped instruments and porous loads. 3. Glassware. B. Accessory program: 1. Dry only Note: The nominal data of the program (default settings) can be changed to fit the needs of a particular office. This is done by means of the TEMP, STE.
4.2 PROGRAM 2. Wrapped Instruments and Porous Loads For wrapped instruments and materials, when the manufacturer recommends autoclaving at temperatures between 250°F and 274°F (121°C and 134°C) with a drying stage. Nominal parameters default settings ♦ Sterilization temperature: 273°F (134°C). ♦ Sterilization time: 7 minutes. ♦ Dry time: 30 minutes. Operations sequence: ♦ Sterilization temperature is maintained constant for the preset sterilization time.
4.3 PROGRAM 3. Glassware For all glassware intended for sterilization. Nominal parameters default settings ♦ Sterilization temperature: 250°F (121°C). ♦ Sterilization time: 30 minutes. ♦ Slow exhaust: 15 to 20 minutes. ♦ Drying time: Drying time is not available in this program. Operations sequence: Heating by actuation of electrical heaters until the sterilization temperature is reached. ♦ Sterilization temperature is maintained constant for the preset sterilization time.
5. PRINTER (Optional) The printer is an optional device. If the autoclave is not equipped with a printer, paragraph 5 is not applicable. 5.1 Printer Operation The autoclave is equipped with a character printer that prints a detailed history of each cycle performed by the instrument (for the record or for subsequent consideration). The printing is made on thermal paper with 24 characters per line and contains the following information: ♦ Software version. ♦ Date and time of cycle start.
PRINTER OUTPUT Autoclave No: 01 Load number: 0005 Operator :___________ O.K. −−−−−−−−−−−−−−−−−−− D20 220°F 00P ----------------------E20 251°F 02P ----------------------S20 273°F 31P * * * S13 273°F 31P S12 273°F 31P ---------------------H08 231°F 10P H04 137°F 00P * * * H00 72°F 00P ---------------------MN TEMP PRES DRY: 30min TIME: 08min TEMP: 273°F PROG: PKG TIME: 15:12:06 DATE: 07:31:00 Version: T01EAWP DESCRIPTION Number of the autoclave with respect to other units in the same location. Load number.
5.2 Printer Handling The printer is driven and controlled automatically by the control unit, while the autoclave performs a sterilization program. Figure 1 Figure 2 To set the paper roll in the printer, perform the following steps: 5.2.1 Gently push the clips for removing the front panel, remove the panel and pull out the printer gently. 5.2.2 Set the paper roll on the shaft (See Figure 1).
6. INSTALLATION INSTRUCTIONS Caution: The sterilizer must be placed on a rigid and leveled surface. The counter must be able to hold the load of the device and loaded material as follows: EZ9 106 48 Model Load on Counter lb kg EZ10, EZ10K 117 53 Note: Make sure while placing the autoclave, to leave space around the machine, to give the technician access to service the machine. 6.1 Electrical The electrical connection should comply with the device's power requirement.
6.2 Water Filling 6.2.1 Automatic Water Filling The proper amount of water for automatic filling in your new Tuttnauer autoclave has been preset at the factory. However, if in routine operation there is inadequate water in the chamber, the operator can adjust the level with the automatic built-in system by doing the following: 1. Press STOP key repeatedly until the message “code xxx” appears on the display. 2. Use the UP or DN arrow keys to change the code to 105, then press the STOP key. 3.
Warning: If it becomes necessary to RESET the software program, it will be essential to repeat all steps listed above. This will ensure that the correct amount of water enters the chamber for operation. VERY IMPORTANT – Due to the fact that the water lines are empty when the unit is shipped, air may become trapped in the lines. It is recommended that for the first operation these steps are followed to make sure water is flowing freely. Open the door, press the Water Inlet key.
6.5 Filling the Water Reservoir Remove the water reservoir cover. Pour distilled water into the reservoir through the opening on top of the autoclave until it reaches the base of the safety valve holder, approximately 0.7 gallons (3 liters). Use water-having characteristics as per table in sec 2.11 Caution: Under no circumstance should water be filled above the safety valve holder. SAFETY VALVE HOLDER EXIT FOR STEAM SPRAY USE DISTILLED WATER ONLY.
7. PREPARATION BEFORE STERILIZATION The purpose of packaging and wrapping items for sterilization is to provide an effective barrier against contamination during storage, once the items have been sterilized. Instruments to be sterilized must be free from all residual matter, such as blood or organic tissue. Instruments must also be dry and free from mineral deposits. Such substances may cause damage to the instruments themselves or the Sterilizer. 1. 2. 3. 4. 5. 6. 7. 8. 9.
13. Verify that packaging methods are in accordance with the good practice approach and the packaging materials used are in agreement with applicable standards. 14. Empty canisters should be placed upsidedown in order to prevent the accumulation of water. 15. Do not overload the Sterilizer trays. Overloading will cause inadequate sterilization & drying. 16. Allow a distance of approximately 1" between trays to permit steam circulation. 17.
21. If spotting is detected on the instruments, the first step would be to use an ordinary eraser to remove the spot. If there is no pitting under the spot then the spot was only dirt. Dirt spots on an instrument may be an indication that the autoclave needs to be cleaned or that the instruments were not adequately cleaned or dried. If removal of the spot reveals pitting, the spot was most likely rust. Rust spots on an instrument are not uncommon on inexpensive instruments.
8. OPERATING INSTRUCTIONS It is important to clean the hole of the air jet, as described in sec. 9.4 before starting operation of the autoclave for the first time. 1. 2. 3. 4. 5. 6. 7. 8. Remove water reservoir cover. Pour distilled water into the reservoir, through the opening on top of the autoclave, until it reaches the base of the safety valve holder, approximately 0.7 gallons (3 liters). Plug the power cord into the back of the autoclave and into the wall outlet.
9. At the end of the cycle a buzzer rings for approximately 5 seconds, the START light switches OFF. The air outlet valve is opened to prevent formation of a vacuum. In the event of a program failure, the exhaust valve is opened to release pressure from the chamber and a continuous buzz will sound for 5 seconds followed by an interrupted buzz of 7 seconds. 10. Open the door and unload the sterilized material from chamber. 11.
MAINTENANCE INSTRUCTIONS 37
9. MAINTENANCE INSTRUCTIONS 9.1 Preventive and Scheduled Maintenance The maintenance operations described in this chapter need to be followed as indicated, to keep the device in good working condition. The instructions that follow can easily be carried out by the office personnel and do not require a service technician. Should the need arise, technical assistance or a serve technician can be requested by either calling your dealer or Tuttnauer USA. 9.1.1 Daily 1.
9.2 Replacing the Air Filter To facilitate drying the instruments with the door of the chamber closed, the autoclave is equipped with an air compressor and HEPA filter (0.2µm). During the drying stage the compressor draws air through the HEPA filter and forces the circulation of that air through the heated chamber to remove moisture from the wrapped instruments. The filtration of the air is performed by the bacteriological filter.
9.3 Draining the Reservoir Caution Before starting, ensure that the electric cord is disconnected and there is no pressure in the autoclave. The drain valve is located on the front left side of the autoclave after the door is opened. The function of the drain valve is to drain the water reservoir. 1. Connect the silicone hose, supplied with the autoclave, to drain into a bucket. 2. Turn drain valve counterclockwise to the open position. 3. Fully drain the reservoir. 4.
9.4 Cleaning the Air Jet (Located in the water reservoir.) A dirty air jet is the number one cause of failed spore tests The elimination of air from the sterilization chamber during heat up is critical to the proper operation of the autoclave. Failure of the air removal system will be responsible for incomplete sterilization, indicator strips that do not turn, failed spore tests and aborted sterilization cycles. A clogged air jet will result in receiving the error message “Low Heat”.
9.5 Replacing the Door Gasket Pull off the gasket from the door groove. Install the new gasket as described in drawings 1, 2 and 3 above. Caution! This gasket is designed with a trapezoidal cross section. The gasket should be placed with the widest side towards the door.
9.6 Checking the Safety Valve (Located in the water reservoir) In order to prevent the safety valve from becoming blocked, it is necessary to allow the steam pressure to escape through the valve. This procedure should be done every month as follows: 1. Operate the sterilization cycle according to the manual. 2. Allow a pressure of approximately 30 psi (207 kpa ) to build up in the chamber. 3. Turn the unit off. 4. Remove water reservoir cover.
9.7 Replacing the Fuse Caution Make sure that the electrical power cord is disconnected! Use a screwdriver to unlock the fuse holder cover by turning it counterclockwise ¼ turn, and pull it out. Insert a new fuse into the holder and turn the cover clockwise until locked. Make sure that the correct fuse is installed 1. Water Pump Fuse: 1.25 amps 2. Air Pump Fuse: 2.0 amps for 120V 1.
9.8 Cleaning Water Outlet Strainer Caution! Before proceeding, make sure that the electric cord is disconnected and there is no pressure or water in the chamber. Warnings 1. The strainer’s cover is HOT Do not touch the strainer’s cap, mounted on the exhaust line, during and shortly after operation. Touching the hot strainer’s cap may cause severe injuries. 2. If maintenance operation is performed while strainer cap is hot, use heat resistant gloves to avoid injuries. 1. Open the strainer cap. 2.
9.9 Cleaning Tabletop Autoclaves with Chamber Brite ™ CHAMBER BRITE ™ is a cleaning and descaling agent designed specifically for the cleaning and removal of water deposits, oxides and other sediments that are found in steam sterilizers. The material is a combination of acidic salts and additional cleaning materials. Chamber Brite ™ autoclave cleaner has been formulated specifically to be a fast, powerful and easy to use cleaner for steam sterilizers.
10. Remove the tray holder; rinse and wipe the interior of the chamber with a damp cloth. 11. Fill the reservoir with distilled water or mineral free water only. 12. Press the manual water fill button and allow a small amount of water (2-4 ounces) to fill chamber and flush out the fill tube. Remove water from chamber. 13. The instrument is ready to use. IMPORTANT: DO NOT sterilize instruments during the cleaning process!!! CAUTION: Keep out of reach of children. Contains mildly acidic ingredients.
9.10 Water Sensor Cleaning It is required that the water sensor be cleaned at least once per week. Cleaning the sensor will ensure that the water level in the chamber is properly reported to the microprocessor all during the cycle. The water sensor is located in the rear of the chamber. It is easily cleaned using a damp cloth or sponge, you may use a mild soapy solution if you like. It is important to wipe the sides of the sensor as well as the tip, to remove any dirt or debris that may have built up.
49 The machine is not responding. ‘Low Heat’ is displayed. ‘Low Water’ is displayed. ‘Low Pres’ is displayed. ‘Low Temp’ is displayed. 2. 3. 4. 5. Problem 5.1 5.2 4.3 4.1 4.2 3.3 3.1 3.2 2.2 2.1 1.4 1.3 1.2 1.1 See Low Water problem above. The sterilization time has been set for too long of a period, allowing the chamber to run dry. Clean the water level electrode inside the vessel, (see sec 9.10).
50 If you are running a ‘glassware’ program, this is normal. The slow exhaust will take from between 15 and 20 minutes, (see, Program 3 sec 4.3). Clean strainer according to instructions, (see sec 9.8). 12.1 13.1 13. Water does not exit chamber due to clogged outlet strainer. Make sure the door is tightened enough and the door gasket is sealing the Chamber. Replace the door gasket, (see sec. 9.5 Replacing the Door Gasket). Make sure the ‘feed button’ on the printer is not stuck. 12.
51 To determine true rust, use a pencil eraser to remove the brown spot. If there is no pitting, the instrument is just dirty (see sec 7, Preparation before sterilizing and sec 9.9, Cleaning the autoclave). If there is pitting beneath the brown spot, the rusting may be caused by minerals in the water used for rinsing (see sec 7, Preparation before sterilizing). Use only distilled water for sterilizing. Make sure dissimilar metals (carbon steel, stainless steel, etc.
52 21.1 22.1 22.2 23.1 23.2 23.3 23.4 24.1 Use Chamber Brite™ to clean the autoclave; very dirty machines may require two cleanings. (see sec 9.9). 25.1 21. Loud noise coming from reservoir. 22. Drying takes too long. 23. Chamber not filling. 24. Chamber very dirty. 25. Trays and rack very dirty. If the problem persists, contact your dealer or Tuttnauer USA for further assistance. Remove the trays and rack and clean as per instructions in sec 9.1.2. Check water level in reservoir.